07.25.26 -- Managing Particulates In Cell Therapy Manufacturing

Greetings! This week’s editorial focus is on cell therapy manufacturing and sterility control.

This guest column with Rafi Mohammad, Ph.D., scientific director at Bayer, explores particulate control strategies in cell therapy manufacturing, a particularly interesting challenge when cells are particles themselves.

In part three of his series on Annex 1 compliance in sterile manufacturing, Pharmatech Associates president and CSO Bikash Chatterjee describes what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance, and how USP measurement tools integrate at each step.

In two related thought pieces, Arnaud Deladeriere, Ph.D., principal consultant at Cell&Gene Consulting Inc., reflects on the current state of allogeneic cell therapies. In this guest column, he explores why so few allogeneic programs have reached late-stage development. He also makes a case for why allogeneic cell therapies should be evaluated on category-specific definitions of success, arguing that allogeneic cell therapies shouldn’t be considered a single modality class.

Before you go, check out some selected content from our partners below — and while you’re at it, be sure to listen to the newest episode of “Better Biopharma,” where AP Biosciences’ Jhong-Jhe You, Ph.D., explains how antibody design can influence product manufacturability.

Tyler Menichiello                                 
Chief Editor, Bioprocess Online

PHC reveals how continuous metabolic monitoring of iPS-derived cardiomyocytes may detect cardiotoxic effects earlier, offering deeper insight into drug safety evaluation.

RoosterBio demonstrates a scalable approach to stem cell-derived exosome purification that boosts recovery, removes impurities, and preserves critical quality attributes.

Terumo BCT is accelerating advances in T-cell immunotherapies, from expanding pipelines to emerging cancer targets and projected market growth through 2030.

AGC Biologics examines how cell and gene therapy innovators are navigating market growth, automation, evolving CDMO partnerships, and scalable manufacturing strategies.

BD Biosciences connects real-time morphological and spatial insights to CAR T cell function, helping researchers better understand next-generation approaches.

Applied StemCell explores the advances in immune-evasion engineering and scalable cell platforms that are paving the way for durable, off-the-shelf therapies.

Bio-Rad provides practical considerations for improving viral clearance and reducing key process- and product-related impurities, supporting more effective and reliable workflows.